NCT02860026撤回不适用
Growth and Tolerance of Healthy Term Infants Fed Cow's Milk-Based Infant Formulas
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 17
- 主要终点
- Rate of body weight gain from 14 to 120 days of age
研究概览
简要总结
This clinical trial will compare the growth and tolerance of infants who consume an investigational cow's milk-based infant formula to those who consume a marketed cow's milk-based infant formula through approximately 4 months of age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 10 Days 至 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Singleton 10-14 days of age at randomization
- •Term infant with birth weight of minimum of 2500 grams
- •Solely formula fed
- •Signed informed consent and protected health information
排除标准
- •History of underlying metabolic or chronic disease, anemia, or immune compromise
- •Feeding difficulties or formula intolerance
研究组 & 干预措施
Control
Active Comparator
Marketed cow's milk-based infant formula
干预措施: Marketed cow's milk-based infant formula (Other)
Investigational
Experimental
Cow's milk-based infant formula with added nutrients
干预措施: Cow's milk-based infant formula with added nutrients (Other)
结局指标
主要结局
Rate of body weight gain from 14 to 120 days of age
时间窗: 3.5 months
次要结局
- Recall of infant formula at each study visit(Up to 3.5 months)
- Recall of stool characteristics questionnaire measured at each study visit(Up to 3.5 months)
- Recall of gastrointestinal tolerance questionnaire at each study visit(Up to 3.5 months)
- Head circumference measured at each study visit(Up to 3.5 months)
- Medically confirmed adverse events collected throughout the study period(Up to 3.5 months)
- Body length measured at each study visit(Up to 3.5 months)
研究者
研究点 (17)
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